多塔利单抗(Dostarlimab-gxly) - 药物靶点：PD-1_在研适应症：晚期子宫内膜癌，复发性子宫内膜癌，MMRD实体瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Dostarlimab、Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer、多斯塔利单抗

+ [10]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病神经系统疾病+ [9]

在研适应症

晚期子宫内膜癌复发性子宫内膜癌MMRD实体瘤+ [81]

非在研适应症

晚期胆管癌透明细胞肉瘤妊娠滋养细胞疾病+ [6]

原研机构

AnaptysBio, Inc.

在研机构

GSK Plc

Tesaro, Inc.GlaxoSmithKline (Ireland) Ltd.

+ [7]

非在研机构-

权益机构

AnaptysBio, Inc.Sagard Healthcare Royalty Partners LP

GSK Plc

+ [1]

最高研发阶段批准上市

首次获批日期

欧盟 (2021-04-21),

MSI-H 子宫内膜癌错配修复缺陷子宫内膜癌

最高研发阶段(中国)临床3期

特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、优先审评 (澳大利亚)

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结构/序列

Sequence Code 315609369H

来源: *****

Sequence Code 315609370L

来源: *****

关联

100

项与多塔利单抗相关的临床试验

NCT07013851

/ Not yet recruiting临床2期IIT

Phase II Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

The study for which participation is requested is a phase II clinical trial to assess the efficacy of dostarlimab as neoadjuvant therapy in patients with MMRd/MSI-H stage II-III endometrial cancer. The study is conducted in Spain with an estimated number of 25 patients for phase II. The main objective of this phase-II study is to evaluate the clinical complete response (cCR) after neoadjuvant therapy with dostarlimab.

开始日期2025-10-01

申办/合作机构

GSK Plc

NCT06897527

/ Not yet recruiting临床4期

Phase 4, Open Label, Non-comparative, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Mismatch Repair Deficient (dMMR)/Microsatellite Instability-high (MSI-H) Recurrent or Advanced Endometrial Cancer (EC) That Has Progressed on or Following Prior Treatment With a Platinum-containing Regimen

The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.

开始日期2025-07-15

申办/合作机构

GSK Plc

NCT06405230

/ Not yet recruiting临床1/2期

A Pilot/Exploratory Translational Study to Evaluate Response to Dostarlimab and Pembrolizumab in Extracellular Vesicles (EVs) or Patient-derived Organoids (PDOs) and by Zirconium-89 Labelled Programmed Death Ligand 1 Positron Emission Tomography in Participants With Recurrent Non-small Cell Lung Cancer

The goal of this clinical trial is to investigate the utility of biomarker tools Extracellular Vesicles (EVs), Patient-derived organoid (PDOs), and PDL1 PET imaging for predicting how participants with recurrent NSCLC respond to standard of care treatment in the advanced/metastatic stages.

开始日期2025-06-27

申办/合作机构

GSK Plc

100 项与多塔利单抗相关的临床结果

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100 项与多塔利单抗相关的转化医学

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100 项与多塔利单抗相关的专利（医药）

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188

项与多塔利单抗相关的文献（医药）

2025-08-01·Gynecologic Oncology Reports

Exacerbation of paraneoplastic cerebellar degeneration by immune checkpoint inhibitor use in endometrial cancer

Article

作者: Tymon-Rosario, Joan ; Danziger, Michael ; Singer, Samuel

Background:

Immune checkpoint inhibitors (ICIs) have transformed the management of advanced and recurrent endometrial carcinoma (EC). ICI therapy can be associated with complex, multisystemic immune-related adverse events (irAEs), which present new challenges in gynecologic oncologic care management. Anti-Yo-positive paraneoplastic cerebellar ataxia (PCA) is a rare syndrome that can be associated with gynecologic malignancies that presents with subacute gait ataxia with imbalance and falls and can demonstrate cerebellar atrophy on imaging.

Case:

Here we describe a patient with stage IVB uterine carcinosarcoma who developed subacute progressive gait ataxia with falls while on maintenance dostarlimab. Neurological workup revealed the presence of anti-Yo antibodies, suggesting a paraneoplastic neurological syndrome (PNS), specifically paraneoplastic cerebellar degeneration (PCD). Dostarlimab was omitted from her subsequent course of treatment, and immunosuppression started with initial improvement followed by stabilization of symptoms.

Conclusion:

This case demonstrates the protean nature and sometimes subtle onset of toxicities associated with these agents, requiring complex coordination of care and multidisciplinary management, particularly as these agents become increasingly important in the management of gynecologic malignancies.

2025-08-01·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Quality-adjusted time without symptoms of disease progression or toxicity of treatment in patients with primary advanced or recurrent endometrial cancer treated with dostarlimab plus carboplatin-paclitaxel versus carboplatin-paclitaxel

Article

作者: Samouëlian, Vanessa ; Antony, Grace ; Mathews, Cara ; Cloven, Noelle G ; Bouberhan, Sara ; Miller, Eirwen M ; McCourt, Carolyn K ; Gropp-Meier, Martina ; Chase, Dana M ; Maćkowiak-Matejczyk, Beata ; Trinidad, Joshua ; Reyners, Anna K L ; Eminowicz, Gemma ; Jain, Angela ; Allonby, Odette ; Powell, Matthew A ; Gill, Sarah E ; Buttin, Barbara ; Garside, Jamie ; Angioli, Roberto ; Boone, Jonathan ; Teneriello, Michael ; Zub, Oleksandr ; Backes, Floor J ; Herrstedt, Jørn ; Braly, Patricia ; Mirza, Mansoor Raza ; Pothuri, Bhavana ; Sawyer, Brandon ; Gilbert, Lucy

OBJECTIVE:

In part 1 of the phase 3 RUBY trial (NCT03981796) in patients with primary advanced or recurrent endometrial cancer, dostarlimab plus carboplatin-paclitaxel significantly improved progression-free and overall survival vs placebo plus carboplatin-paclitaxel. Post hoc analyses examined the impact of adding dostarlimab to chemotherapy, compared with placebo plus chemotherapy, on quality-adjusted time without symptoms of disease progression or toxicity of treatment in this patient population.

METHODS:

Patients were randomized 1:1 to receive dostarlimab/placebo plus chemotherapy every 3 weeks for 6 cycles, followed by dostarlimab/placebo monotherapy every 6 weeks for up to 3 years. Data from the first interim analysis (September 28, 2022) were used, and quality of life (QoL) was assessed with the EuroQoL 5-Dimensions 5-Level questionnaire. Quality-adjusted time without symptoms of disease progression or toxicity of treatment was calculated as the sum product of the restricted mean survival times spent in 3 mutually exclusive states: toxicity, time without symptoms of disease progression or treatment toxicity, and relapse, and utilized each state's corresponding QoL.

RESULTS:

In the dostarlimab and placebo arms, 241 and 246 patients were analyzed for safety, respectively. In the overall population, the mean (95% CI) duration of quality-adjusted time without symptoms of disease progression or toxicity of treatment was significantly longer in the dostarlimab arm (24.75 months [22.88 to 26.65 months]) than in the placebo arm (20.34 months [18.95 to 21.76 months]; the mean difference [95% CI] of 4.41 months [2.01 to 6.77 months], p < .001). Benefits in quality-adjusted time without symptoms of disease progression or toxicity of treatment after dostarlimab treatment were observed regardless of mismatch repair/microsatellite instability status or toxicity criteria used and were predominantly driven by the time without symptoms of disease.

CONCLUSIONS:

Dostarlimab plus carboplatin-paclitaxel treatment is associated with meaningful improvement in survival, avoidance of substantial toxicity, and maintenance of patient-reported QoL in patients with primary advanced or recurrent endometrial cancer.

2025-07-01·ANTICANCER RESEARCH

Immunotherapy and Chemotherapy for Advanced or Recurrent Endometrial Carcinoma

Review

作者: Bohart, Randy D ; Goldstein, Bram H ; Gorman, Joshua P ; Micha, John P

Patients with early-stage endometrial cancer are frequently treated with surgery and radiotherapy or chemotherapy, for which 5-year survival rates approach 95%; conversely, the outcomes for patients with advanced or recurrent endometrial cancer are more inauspicious. Fortunately, the advent of immunotherapy, combined with chemotherapy, has conferred improved survival, especially in endometrial cancer patients with a mismatch repair deficiency (dMMR). We conducted an extensive PubMed search on the topics of endometrial cancer and immunotherapy treatment. The combination of dostarlimab and chemotherapy reportedly coincides with a 2-year progression-free survival (PFS) of 61% compared to a 12-month PFS of 74% for pembrolizumab. Moreover, the follow-up data for dostarlimab extended beyond 44 months and the median overall survival (OS) has not been reached compared to more limited OS data for both pembrolizumab and durvalumab; additionally, dostarlimab's pronounced risk of disease progression or death in both dMMR (70%) and mismatch repair-proficient (pMMR) (46%) patients is considerable. While pembrolizumab, dostarlimab and durvalumab with chemotherapy are associated with beneficial outcomes in advanced-stage or recurrent endometrial cancer, dostarlimab has distinguished itself with unsurpassed survival data compared to pembrolizumab and durvalumab.

468

项与多塔利单抗相关的新闻（医药）

2025-07-26

·ioncology

新辅助治疗成新宠！2025 ASCO 黑色素瘤围术期治疗进展

编者按：2025年美国临床肿瘤学会（ASCO）已经落下帷幕，全球肿瘤学同道见证了许多重磅研究正在或即将改变临床实践。在黑色素瘤围术期治疗领域有多项研究作为延迟突破性摘要（LBA）在大会上公布，尤其术前新辅助治疗取得不少突破性进展，围绕新辅助和辅助治疗的“掰头”仍在持续升级。《肿瘤瞭望》特邀北京大学肿瘤医院斯璐教授、王稼祥医生总结和点评ASCO黑色素瘤围术期研究进展如下。01新辅助治疗随着SWOG 1801和NADINA两项新辅助临床研究结果公布，黑色素瘤进入新辅助治疗时代。相比单纯术后辅助， PD-1单抗新辅助将III期皮肤型黑色素瘤2年复发风险降低了23%；PD-1单抗联合CTLA-4单抗新辅助治疗将1年无事件生存（EFS）率提升到了83.7%（单纯辅助组57.2%），且59%的患者达到主要病理缓解（MPR）从而免去了后续长期辅助治疗[1,2]。免疫单药与联合、其他免疫检查点的应用以及其他亚型新辅助方案的探索仍是目前值得探索的方向。II期患者从单免新辅助治疗中获益有限SWOG 1801研究已经证实了帕博利珠单抗（PD-1单抗）单药新辅助在III期皮肤型患者中能显著降低复发风险，其在II期黑色素瘤患者的疗效尚需探索[1]。美国宾州大学附属医院牵头的一项II期新辅助研究评估了帕博利珠单抗在临床IIB-IIC期皮肤黑色素瘤中的应用，研究共纳入64例患者，术前帕博利珠单抗新辅助后继续辅助治疗1年。结果显示，新辅助治疗组总体前哨淋巴结（SLN）阳性率未显著降低（P=0.384）；但IIC亚组SLN阳性率降低了23.3%（P=0.009）。中位随访20.4个月时，2年无复发生存率（RFS）为81%，远处无转移生存率（DMFS）88%。该研究2年RFS率与KEYNOTE 716（81.2%）和CHECKMATE 76K（78%）结果类似[3,4]。三药联合为肢端新辅助带来新变革替莫唑胺联合阿帕替尼及卡瑞丽珠单抗的三药联合方案已在晚期肢端黑色素瘤一线治疗中取得了较好效果（ORR 64%，中位PFS 18.4个月）[5]。同样由该团队主导的CAP 03-NEO II期研究创新性地采用两阶段设计，评估了卡瑞利珠单抗联合阿帕替尼及替莫唑胺三药联合方案在可切除II/III期肢端型黑色素瘤新辅助治疗中的疗效。研究纳入30例患者（II期11例，III期19例），28例接受手术的患者中病理缓解率达57.1%（含7例pCR和5例near-pCR），III期患者的MPR率显著高于II期（42.9% vs 36.7%）。中位随访18.1个月显示，12个月EFS率达77.6%（III期患者75%），达到MPR的患者1年EFS率为100%。更多双免联合方案证据及探索2024年公布的III期临床研究数据，纳武利尤单抗（NIVO）联合伊匹木单抗（IPI）在III期黑色素瘤新辅助治疗中降低了26.5%的1年复发风险，pCR（病理完全缓解）率达到了47.2%，MPR的患者1年RFS（无复发生存）率达到了95.1%[2]。今年ASCO大会上，同样是NIVO+IPI新辅助的II期C-IT Neo trial研究报道了相似的结果，pCR率达45.4%，MPR患者1年RFS率为100%，但此研究仅纳入了22例患者。更多免疫检查点抑制剂联合方案在新辅助中的疗效也在探索中。在美国开展的II期临床试验NeoACTIVATE的Arm C队列中，阿替利珠单抗（PDL-1单抗）联合tiragolumab（TIGIT单抗）的双免疫疗法在III期高危可切除黑色素瘤患者新辅助中pCR率达38.2%，1年EFS率72%，1年RFS和DMFS分别为73.3%和86%。另一项III期随机非对照新辅助NEO-MEL-T研究对比Dostarlimab（PD-1单抗）单药新辅助同Dostarlimab+Cobolimab（TIM-3单抗）联合新辅助的效果，对比Dostarlimab单药新辅助，联合新辅助组的pCR率仅提高了3.7%（37% vs 33.3%），但MPR率提高了22.3%（55.6% vs 33.3%），影像评估中ORR（客观缓解率）提高了1倍（33.3% vs 16.7%），不过两组中位RFS无显著差异。点评黑色素瘤新辅助治疗近年来备受关注，免疫单药或联合的选择是目前皮肤型黑色素瘤探索的方向之一。PD-1单抗新辅助在II期皮肤型黑色素瘤中整体呈阴性结果，但IIC期患者SLN阳性率显著降低，双免疫新辅助方案中，PD-1单抗+CTLA-4单抗的联合方案相较于其他免疫检查点抑制剂的联合似乎更能降低复发转移风险。三药联合方案在肢端亚型中取得了和双免在皮肤型新辅助中类似的MPR率，为中国黑色素瘤新辅助治疗方案提供了参考。如何能在降低复发转移风险的同时延长OS，是未来新辅助研究应该关注及解决的问题。02辅助治疗目前NCCN指南已将PD-1单抗及达拉非尼+曲美替尼双靶方案作为III期皮肤型黑色素瘤辅助治疗推荐，II期患者是否也能达到相似的获益，免疫联合辅助治疗方案能否使患者进一步获益，以及其他分型黑色素瘤的辅助治疗模式的探索是值得关注的方向。双免辅助未优于单免辅助2024年ESMO大会上公布了KEYNOTE 054的7年随访结果，PD-1单抗单药辅助可降低III期皮肤型黑色素瘤14%的复发风险（PD-1单抗50% vs安慰剂组36%）。但双免是否能进一步降低复发风险，为此，RELATIVITY 098研究在III-IV期黑色素瘤开展了LAG3单抗Relatilimab联合Nivolumab对比Nivolumab单药辅助的多中心3期临床试验，经中位随访26.7个月后，两组RFS无显著差异。NIVO+RELA和NIVO单药组的1年RFS率分别为75%和72%，2年RFS率62%和64%。双靶方案在II期辅助中安全性探索达拉非尼联合曲美替尼在BRAF突变的III期皮肤黑色素瘤辅助中可降低32%的1年复发风险（1年RFS 88% vs 安慰剂56%），4年RFS率提升了16%（54% vs 38%）[6,7]。在II期BRAF-V600E/K突变皮肤型患者中，今年ASCO大会中的EORTC-2139-MG/Columbus-AD III期研究显示，BRAF抑制剂Encorafenib联合MEK抑制剂Binimetinib（E+B）辅助治疗的1年RFS率提升了16%（86% vs 70%），DMFS率为92%（安慰剂组82%）。尽管安全性可控（3级以上毒性24%），但因PD-1单抗在同类适应症中的优先获批（如KEYNOTE-716的1年RFS 90%），该研究提前终止，仅入组110例患者，最终转为安全性探索性分析。点评今年黑色素瘤辅助研究结果多为阴性，对阴性结果原因的探讨或许能为未来的研究提供思考。RELATIVITY 098中NIVO联合RELA辅助相较于NIVO单药并未显著降低复发风险，进一步T细胞亚群变化分析提示晚期患者LAG-3+ T细胞水平更高且治疗后 LAG-3+ T 细胞的增加较辅助患者更为显著。这或许可以说明肿瘤存在的时候具有更强的免疫原性，因此可能可以解释在晚期治疗RELATIVITY-047中免疫联合治疗效果更佳。Columabus-AD的双靶辅助研究无疾而终，但对于呈独特的“冷肿瘤”特征的中国黑色素瘤，靶向辅助治疗或许仍有望成为后续辅助治疗探索方向之一。随着新辅助研究中MPR率的不断提高，根据不同的病理缓解率来设计后续辅助治疗方案将成为未来辅助治疗的趋势。参考文献上下滑动查看更多内容[1].Patel SP, Othus M, Chen Y, Wright GP, Jr., Yost KJ, Hyngstrom JR, Hu-Lieskovan S, Lao CD, Fecher LA, Truong TG et al: Neoadjuvant-Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma. N Engl J Med 2023, 388（9）:813-823.[2].Blank CU, Lucas MW, Scolyer RA, van de Wiel BA, Menzies AM, Lopez-Yurda M, Hoeijmakers LL, Saw RPM, Lijnsvelt JM, Maher NG et al: Neoadjuvant Nivolumab and Ipilimumab in Resectable Stage III Melanoma. N Engl J Med 2024, 391（18）:1696-1708.[3].Luke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, de la Cruz Merino L, Khattak MA, Schadendorf D, Long GV et al: Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma （KEYNOTE-716）: a randomised, double-blind, phase 3 trial. Lancet 2022, 399（10336）:1718-1729.[4].Kirkwood JM, Del Vecchio M, Weber J, Hoeller C, Grob JJ, Mohr P, Loquai C, Dutriaux C, Chiarion-Sileni V, Mackiewicz J et al: Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial. Nat Med 2023, 29（11）:2835-2843.[5].Mao L, Lian B, Li C, Bai X, Zhou L, Cui C, Chi Z, Sheng X, Wang X, Tang B et al: Camrelizumab Plus Apatinib and Temozolomide as First-Line Treatment in Patients With Advanced Acral Melanoma: The CAP 03 Phase 2 Nonrandomized Clinical Trial. JAMA Oncol 2023, 9（8）:1099-1107.[6].Hauschild A, Dummer R, Schadendorf D, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C et al: Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600-Mutant Stage III Melanoma. J Clin Oncol 2018, 36（35）:3441-3449.[7].Long GV, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A et al: Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma. N Engl J Med 2017, 377（19）:1813-1823.斯璐教授北京大学肿瘤医院黑色素瘤及肉瘤内科，主任医师，博士生导师《CSCO黑色素瘤诊治指南》执笔人《CSCO免疫检查点抑制剂相关毒性管理指南》执笔人CSCO黑色素瘤专家委员会副主任委员CSCO神经系统肿瘤专委会副主任委员《肿瘤学杂志》青年编委、副主编Clinical Cancer Research审稿专家王稼祥北京大学临床肿瘤学院肿瘤内科博士北京大学肿瘤医院肾癌黑色素瘤内科住院医师主要研究方向：黑色素瘤的靶向、免疫、化疗等综合治疗（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床结果临床3期临床2期

2025-07-15

·癌度

《癌度早报》2025年7月15日

临床试验病友交流群（点击）一、新药快讯1、HER3的抗体偶联药德帕曲妥珠单抗，治疗乳腺癌显示积极效果与EGFR和HER2属于同一个家族的HER3也有抗体偶联药，该药就是Patritumab deruxtecan，中文翻译为德帕曲妥珠单抗，根据最新公布的临床试验结果，该药对乳腺癌脑转移患者有比较好的治疗效果，21名乳腺癌脑转移患者中，23.8%的患者用药后脑部病灶缩小，疾病控制率达到了61.9%，临床获益率达到了33.3%，中位无进展生存时间达到了4个月。2、新型癌症疫苗让免疫力倍增，9名患者100%起效！最近，美国丹娜法伯癌症研究院主导的一项临床试验结果表明，针对黑色素瘤患者的个性化癌症疫苗NeoVax进行了升级，升级的版本疫苗不仅安全可行，而且激发患者的免疫系统方面更强。发布在《Cell》的研究表明，9名患者接种疫苗之后产生了积极应答，其中6名患者的抗癌免疫反应显著增强，本次临床试验还调整了疫苗注射方式，接种前后注射了PD-1抑制剂纳武利尤单抗，疫苗注射部位皮下注射了CTLA-4抑制剂伊匹木单抗。3、晚期子宫内膜癌新疗法面试，任何年龄段都有效果近日，一项重磅研究表明，一款名为多塔利单抗（Dostarlimab）的免疫药物和常规化疗搭配，可以显著延长晚期子宫内膜癌患者的肿瘤控制时间。而且不管是30岁还是70岁的病人都有效果，多塔利单抗是一种PD-1抑制剂，多塔利单抗联合化疗治疗子宫内膜癌的肿瘤控制时间比对照组多5个月，而且不管患者是不是微卫星不稳定型都适用。二、抗癌前沿1、手术之前使用免疫治疗，手术后4年8成患者不会复发最近，来自世界癌症排名第一的MD安德森癌症中心的一项研究表明，大多数晚期黑色素患者，手术之前使用双免疫疗法之后再做手术，4年之后大多数患者仍然健在，而且8成的患者没有发生复发。不过需要说明的是这两款药物分别是PD-1抑制剂纳武利尤单抗（Nivolumab），另一款药物则是LAG-3免疫药物瑞来利单抗（Relatlimab）。而且病理显示大量癌细胞在手术之前就被免疫疗法杀死，手术后95%的患者4年未复发。参加抗癌新药临床试验，请关注“癌度”微信公众号，回复数字 “1” 咨询！

免疫疗法临床结果疫苗临床2期

2025-07-09

·GlobeNewswire-Health Care

New Clinical Findings Published in Scientific Journal Nature Validate LIXTE’s Ongoing Ovarian and Colorectal Cancer Trials

Article Indicates that Inhibition of PP2A Enhances Immunotherapy Responsewith LIXTE’s Proprietary Compound LB100 PASADENA, Calif., July 09, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced that the medical journal Nature has published findings by a team of physician-scientists that validate LIXTE’s ongoing clinical trials with its proprietary compound LB100 for Ovarian and Colorectal cancers (https://www.nature.com/articles/s41586-025-09203-8). A team led by principal investigator Amir Jazaeri, MD, professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, studied survival outcomes of Ovarian Clear Cell Carcinoma (OCCC) patients treated with immune checkpoint blockade therapy (clinicaltrials.gov identifier: NCT03026062). The ;study showed that patients having tumors with inactivating mutations in PPP2R1A - the major scaffold subunit of protein phosphatase 2A (PP2A) - had significantly better overall survival, compared with patients who did not have this mutation in their tumors. Inactivating mutations in PPP2R1A are known to reduce the enzymatic activity of PP2A, which is the target of LIXTE’s lead compound LB-100. Tumors with mutations in PPP2R1A were found to have increased the interferon gamma response pathway, which is known to be associated with improved immune checkpoint responses. LIXTE is currently investigating the activity of LB-100 in combination with checkpoint immunotherapy in two clinical trials. The first is enrolling patients with OCCC, led by Dr. Jazaeri at MD Anderson Cancer Center, and also is open at Northwester University. In this trial, LIXTE is collaborating with GSK to test LB-100 in combination with dostarlimab (anti PD1). In the second trial, at the Netherlands Cancer Institute, LIXTE is collaborating with Roche to test LB-100 in combination with atezolizumab (anti PDL1) in colon cancer patients. “Not only did we identify a new biomarker for improved survival with immunotherapy in ovarian cancer, but we also confirmed the correlation of this biomarker with survival benefit in other cancer types,” said Dr. Jazaeri, who was co-senior author of the Nature article. “Since PPP2R1A mutations are relatively uncommon, we believe the same benefits may be possible by targeting the PPP2A pathway using drugs, which we currently are evaluating in a clinical trial at MD Anderson.” Bas van der Baan, LIXTE’s Chief Scientific Officer, added, “This work extends a body of pre-clinical evidence indicating that LB-100 is strongly synergistic with checkpoint immunotherapy in a range of cancer types. We look forward to the first results of our clinical studies in the second half of this year.” About LIXTE Biotechnology Holdings, Inc. LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on new targets for cancer drug development and developing and commercializing cancer therapies. LIXTE has demonstrated that its first-in-class lead clinical PP2A inhibitor, LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on extensive published preclinical data (see www.lixte.com), LB-100 has the potential to significantly enhance chemotherapies and immunotherapies and improve outcomes for patients with cancer. LIXTE’s lead compound, LB-100, is part of a pioneering effort in an entirely new field of cancer biology – activation lethality – that is advancing a new treatment paradigm. LIXTE's new approach is covered by a comprehensive patent portfolio. Proof-of-concept clinical trials are currently in progress for Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer and Advanced Soft Tissue Sarcoma. Additional information about LIXTE can be found at www.lixte.com. Forward-Looking Statement Disclaimer This announcement contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. For example, statements regarding the Company's financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future activities, including the continuing development of proprietary compounds, the planning, funding, coordination and potential results of clinical trials, the patent and legal costs to protect and maintain the Company's intellectual property worldwide, and the Company’s ability to obtain and maintain compliance with Nasdaq’s continued listing requirements, are all forward-looking statements. These statements are generally accompanied by words such as "intend," anticipate," "believe," "estimate," "potential(ly)," "continue," "forecast," "predict," "plan," "may," "will," "could," "would," "should," "expect" or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that the Company may presently be planning. However, these forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected or anticipated in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, available cash resources, research results, competition from other similar businesses, and market and general economic factors. Readers are urged to read the risk factors set forth in the Company’s filings with the United States Securities and Exchange Commission at https://www.sec.gov. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For more information about LIXTE, Contact: For more information about LIXTE, Contact: info@lixte.com General Phone: (631) 830-7092; Investor Phone: (888) 289-5533orPondelWilkinson Inc. Investor Relations pwinvestor@pondel.comRoger Pondel: (310) 279-5965; Laurie Berman: (310) 279-5962

免疫疗法临床研究临床结果

100 项与多塔利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	多塔利单抗	L01XC	DB15627

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
晚期子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
晚期子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
晚期子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
MMRD实体瘤	美国	GlaxoSmithKline LLC	2021-08-17
MSI-H 子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
MSI-H 子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
MSI-H 子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
MSI-H 子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2021-04-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
PD-L1阳性非小细胞肺癌	临床3期	美国	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	中国	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	日本	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	阿根廷	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	比利时	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	巴西	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	保加利亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	加拿大	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	芬兰	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	法国	GSK Plc	2024-06-10

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03574779 (OPAL Phase II Trial \| OPAL, CTgov)	临床2期	卵巢癌	77	Niraparib+Bevacizumab+Dostarlimab (Cohort A (Dostarlimab + Bevacizumab + Niraparib))	醖鏇淵淵簾窪淵廠簾艱 = 廠鬱糧膚積觸淵夢餘簾艱淵鏇衊夢鏇選繭膚鏇 (蓋衊衊鏇繭餘廠鹹構繭, 蓋製艱廠膚憲醖鑰糧餘 ~ 選廠顧鑰鏇積糧簾餘鹽) 更多	-	2025-07-15
				taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane))	醖鏇淵淵簾窪淵廠簾艱 = 鬱襯鹹憲願選齋艱顧鬱艱淵鏇衊夢鏇選繭膚鏇 (蓋衊衊鏇繭餘廠鹹構繭, 壓齋積憲淵餘淵蓋顧艱 ~ 醖願蓋糧遞糧膚鏇鹹窪) 更多
NCT03981796 (ENGOT-EN6-NSGO/GOG-3031/RUBY, ASCO2025)	临床3期	复发性子宫内膜癌 dMMR/MSI-H \| MMRp/MSS	494	Dostarlimab plus Carboplatin-Paclitaxel (DOST+CP)	壓壓窪鏇衊繭獵齋顧鬱(構廠醖淵築鹽憲繭願鑰) = 鬱範鏇鹹蓋廠顧淵觸衊廠選遞製壓遞憲觸選糧 (網衊蓋遞壓憲選艱選顧 ) 更多	积极	2025-05-30
				Placebo plus Carboplatin-Paclitaxel (PBO+CP)	壓壓窪鏇衊繭獵齋顧鬱(構廠醖淵築鹽憲繭願鑰) = 顧鑰窪廠製夢遞構襯製廠選遞製壓遞憲觸選糧 (網衊蓋遞壓憲選艱選顧 ) 更多
NCT04165772 (NEWS \| Pubmed) 人工标引	临床2期	MSI-H 癌症 \| 错配修复缺陷直肠癌新辅助 Deficient DNA Mismatch Repair (dMMR)	117	Dostarlimab	鏇憲繭鬱蓋淵壓顧餘繭(衊製網簾廠遞製襯製齋) = 艱獵鏇艱範鬱淵醖襯糧鹽鹽鬱網衊鑰鬱艱獵構 (鹽鹹窪廠衊衊憲顧範襯 ) 更多	积极	2025-04-27
				Dostarlimab (dMMR, locally advanced rectal cancer)	鬱鏇鬱鹹簾積艱築觸獵(淵壓廠壓顧艱顧築窪簾) = 齋範膚顧襯衊積鬱鏇淵繭選鑰繭簾艱蓋壓糧艱 (簾膚壓淵糧廠餘廠範齋 ) 更多
NCT02715284 (GARNET, AACR2025)	临床1期	非小细胞肺癌	67	dostarlimab (SerialCTRS)	顧網築簾齋積顧簾糧憲(膚鹹窪鹹製簾製衊簾壓): HR = 2.68 (95% CI, 1.09 ~ 6.59), P-Value = 0.03	积极	2025-04-27
				dostarlimab (RECIST 1.1)
NCT04581824 (PERLA, ESMO_ELCC2025)	临床2期	转移性非鳞状非小细胞肺癌一线 PD-L1 status	-	Dostarlimab plus chemotherapy	醖構鏇淵鬱範糧網範憲(淵糧網鹹顧餘築壓夢膚) = 糧廠糧選鹹觸鑰範獵憲構憲構積鬱廠艱選餘獵 (壓醖齋壓繭鑰齋廠構淵, 14.5 ~ 27.3) 更多	积极	2025-03-26
				Pembrolizumab plus chemotherapy	醖構鏇淵鬱範糧網範憲(淵糧網鹹顧餘築壓夢膚) = 壓簾選膚繭襯鬱繭鹹觸構憲構積鬱廠艱選餘獵 (壓醖齋壓繭鑰齋廠構淵, 11.6 ~ 19.3) 更多
NCT06655818 (CTgov)	临床1/2期	多发性骨髓瘤	4	Mafodotin+Dostarlimab+Belantamab	顧蓋範餘衊觸膚簾製膚 = 鹽選獵繭遞繭壓簾餘蓋顧夢襯鑰鬱顧網淵願糧 (廠窪顧製膚觸鬱繭膚繭, 鹹鹽網餘網夢選艱齋艱 ~ 願觸構鏇願獵範獵選醖) 更多	-	2025-03-03
NCT03250832 (CITRINO, Pubmed)	临床1期	晚期恶性实体瘤	-	Encelimab + Dostarlimab	製淵構齋糧鹹膚襯構構(獵艱積齋醖鬱襯壓膚選) = 夢築壓憲壓繭構繭網醖鑰壓鹹窪網鬱壓壓鬱糧 (襯鏇糧艱醖窪遞構醖鏇 )	不佳	2025-02-27
				Dostarlimab	製淵構齋糧鹹膚襯構構(獵艱積齋醖鬱襯壓膚選) = 顧衊構繭壓構鹽壓構鹽鑰壓鹹窪網鬱壓壓鬱糧 (襯鏇糧艱醖窪遞構醖鏇 )
NCT03602859 (FIRST-ENGOT-OV44, PipelineReview) 人工标引	临床3期	卵巢癌一线	-	SOC + Placebo	網餘膚網夢選遞鏇遞網(廠壓構艱繭餘獵襯選構) = The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab. 構夢鑰鹹鹹範艱蓋鏇膚 (醖顧簾蓋壓網製積繭蓋 ) 达到更多	积极	2024-12-20
				SOC + niraparib
NCT05723562 (AZUR-1, Company_Website) 人工标引	临床2期	错配修复缺陷直肠癌一线 MSI-High \| Deficient DNA Mismatch Repair (dMMR)	42	dostarlimab	鹽衊獵顧蓋顧餘網築醖(醖鑰醖願願壓鬱淵窪網) = 遞淵壓壓獵鬱襯繭壓衊蓋夢顧網餘夢獵鬱網簾 (網願獵艱鬱糧蓋艱鬱選 )	积极	2024-12-16
Korean expanded access program (ESMO_ASIA2024)	N/A	复发性子宫内膜癌 dMMR \| MSI-H	29	Dostarlimab 500mg	鏇繭襯構壓餘網憲構鑰(築壓餘蓋製糧願襯艱願) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment 淵選窪艱壓夢夢憲淵選 (艱襯糧襯範積衊鬱遞築 ) 更多	积极	2024-12-07